CTRI/2021/07/034990尚未招募2 期
Primary Surgery versus Primary Chemoradiation for Oropharyngeal Cancer (SCOPe trial) â??A Phase II/III Integrated Design Randomized Control Trial. - SCOPe
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Histopathology proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil and /or lateralized tongue-base
- •2. ECOG Performance Status <=2
- •3. Age >=18 to 70 years
- •4. Anesthetic fitness obtained for surgery under general anesthesia
- •5. Resectable primary tumor with an anticipation of achieving resection free margins either by minimally invasive/open techniques
- •6. Clinical stage III or IV, i.e. T1 T2 or T3 -T4 with N0-N3.
- •Nodal disease with extranodal extension on clinical examination/
- •imaging may be included at the surgeonâ??s discretion, if the nodal disease is deemed resectable by the operating surgeon
- •7. HPV negative status determined by p16 status
- •8. No distant metastases below the clavicles, based upon the following minimum
- •diagnostic workup:
- •a.History/physical examination by the physician
- •b.Imaging of the head and neck (Contrast enhanced MRI for local workup and Chest CT/PET-CT for distant metastatic workup)
- •9. Patients with no contraindications to Cisplatin chemotherapy
- •and radiotherapy
- •10. Adequate organ function
- •a. Hematological- Hb > 10 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
- •b. Liver functions - bilirubin <= 2 x upper limit normal (ULN), AST/ALT/ALP <= 2.5 x ULN, S. albumin >= 30 g/L.
- •c.Renal function - Creatinine <= 1.5 ULN, Creatinine clearance > 50 mL/min.
- •11. Women of child bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial
- •12. Patients who can be followed up and must be able to provide informed consent prior to study entry
排除标准
- •1. Prior head and neck malignancy
- •2. Prior invasive malignancy, unless disease free for a minimum of 3 years
- •3. Prior chemotherapy for a different cancer administered
- •within 3 years prior to registration
- •4. Patients who have received any neoadjuvant/ induction chemotherapy
- •5. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation therapy fields
- •6. Unresectable primary or nodal disease involving the carotid vessels, prevertebral fascia or skull base
- •7. Large soft palate involvement >1 cm 8. Deep extension into larynx,
- •pre-epiglottic space and deep invasion into extrinsic
- •muscles of tongue
- •9. Calculated GFR < 50 cc/min
- •10.Patients who have uncontrolled cardiac
- •co morbidity
- •a.QTc prolongation (a value of >450 milliseconds)
- •b.Ejection fraction below 50%
- •c.Presence of regional wallakinesia
- •11. Presence of previous episode of thrombosis or embolism or presence of a prothrombotic condition in last 1 year
- •12. Presence of severe malnutrition as defined by body mass index of below 16kg per m2 or presence of weight loss of greater than 20% in la
- •st 6 months
- •13. Severe active comorbidities such as severe cardiac failure, severe pulmonary compromise, type 1or 2 diabetes mellitus (Hb1ac of > 8 mg/dl) severe and active infections or life expectancy less than 6 months
- •14. Prior allergic reaction to cisplatin
- •15. Radiographic evidence of retropharyngeal and/or level VI metastasis
- •16. Patients on other investigational drugs within last 30 days
研究者
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